TNKase? (Tenecteplase) - Genentech, Inc. - Marketed Lyophilized Drug Products

WARNINGS
Bleeding
The most common complication encountered during TNKase therapy is bleeding. The type of bleeding associated with thrombolytic therapy can be divided into two broad categories:
Internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or sites of recent surgical intervention.
Should serious bleeding (not controlled by local pressure) occur, any concomitant heparin or antiplatelet agents should be discontinued immediately.
In clinical studies of TNKase, patients were treated with both aspirin and heparin. Heparin may contribute to the bleeding risks associated with TNKase. The safety of the use of TNKase with other antiplatelet agents has not been adequately studied (see PRECAUTIONS: Drug Interactions). Intramuscular injections and nonessential handling of the patient should be avoided for the first few hours following treatment with TNKase. Venipunctures should be performed and monitored carefully.
Should an arterial puncture be necessary during the first few hours following TNKase therapy, it is preferable to use an upper extremity vessel that is accessible to manual compression. Pressure should be applied for at least 30 minutes, a pressure dressing applied, and the puncture site checked frequently for evidence of bleeding.
Each patient being considered for therapy with TNKase should be carefully evaluated and anticipated benefits weighed against potential risks associated with therapy. In the following conditions, the risk of TNKase therapy may be increased and should be weighed against the anticipated benefits:
Recent major surgery, e.g., coronary artery bypass graft, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels
Cerebrovascular disease
Recent gastrointestinal or genitourinary bleeding
Recent trauma
Hypertension: systolic BP > 180 mm Hg and/or diastolic BP > 110 mm Hg
High likelihood of left heart thrombus, e.g., mitral stenosis with atrial fibrillation
Acute pericarditis
Subacute bacterial endocarditis
Hemostatic defects, including those secondary to severe hepatic or renal disease
Severe hepatic dysfunction
Pregnancy
Diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions
Septic thrombophlebitis or occluded AV cannula at seriously infected site
Advanced age (see PRECAUTIONS: Geriatric Use)
Patients currently receiving oral anticoagulants, e.g., warfarin sodium
Recent administration of GP IIb/IIIa inhibitors
Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location
Cholesterol Embolization
Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown. This serious condition, which can be lethal, is also associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy. Clinical features of cholesterol embolism may include livedo reticularis, "purple toe" syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, and rhabdomyolysis.
Arrhythmias
Coronary thrombolysis may result in arrhythmias associated with reperfusion. These arrhythmias (such as sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, ventricular tachycardia) are not different from those often seen in the ordinary course of acute myocardial infarction and may be managed with standard anti-arrhythmic measures. It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered.
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